Condition category
Pregnancy and Childbirth
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
12/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lindsay Smith

ORCID ID

Contact details

East Somerset Research Consortium
Westlake Surgery
High Street
West Coker
BA22 9AH
United Kingdom
+44 (0)1935 862624
research@esrec.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

R/29/10.99/Smith

Study information

Scientific title

Acronym

MIST

Study hypothesis

Main research question: Which of three management methods (expectant, medical or surgical) of failed first trimester pregnancy (missed or incomplete miscarriage) is associated with least gynaecological infection.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Pregnancy; miscarriage

Intervention

1. Expectant management
2. Medical management
3. Surgical management

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Gynaecological infection within 14 days of randomisation.

Secondary outcome measures

1. Bleeding & pain
2. Retained products by scan at 10-14 days
3. Depression
4. Anxiety
5. Return to normal activity
6. Complications by 6 weeks

Overall trial start date

01/04/1997

Overall trial end date

31/10/2001

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women with a failed pregnancy of <13 weeks gestation
2. Attending the early pregnancy assessment clinics of Southmead Hospital, Bristol or the Royal United Hospital, Bath
3. Informed consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1200 women were recruited: 399 to expectant management, 398 to medical management, and 403 to surgical management (added 12/01/10, see publication)

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/04/1997

Recruitment end date

31/10/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

East Somerset Research Consortium
West Coker
BA22 9AH
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive South West (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16707509
2. 2006 economic evaluation in http://www.ncbi.nlm.nih.gov/pubmed/16827823
3. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19815581

Publication citations

  1. Results

    Trinder J, Brocklehurst P, Porter R, Read M, Vyas S, Smith L, Management of miscarriage: expectant, medical, or surgical? Results of randomised controlled trial (miscarriage treatment (MIST) trial)., BMJ, 2006, 332, 7552, 1235-1240, doi: 10.1136/bmj.38828.593125.55.

  2. Economic evaluation

    Petrou S, Trinder J, Brocklehurst P, Smith L, Economic evaluation of alternative management methods of first-trimester miscarriage based on results from the MIST trial., BJOG, 2006, 113, 8, 879-889, doi: 10.1111/j.1471-0528.2006.00998.x.

  3. Results

    Smith LF, Ewings PD, Quinlan C, Incidence of pregnancy after expectant, medical, or surgical management of spontaneous first trimester miscarriage: long term follow-up of miscarriage treatment (MIST) randomised controlled trial., BMJ, 2009, 339, b3827.

Additional files

Editorial Notes